AMD Ritmed AssureWear VersaGown
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190306 FDA 510(k)
- FDA Product Code
- FYC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an isolation gown, surgical, classified as a gown under FDA device classification. It is a multi-layer SMS (spunbond-meltblown-spunbond) isolation gown designed to provide fluid protection, breathability, and comfort.
The gown features thumb loops, extended thumb loops, and elastic cuff options, and incorporates patented Flexneck™ technology for fast and easy over-the-head donning and safe doffing to prevent self-contamination. It is rated AAMI Level 1 and 2, supplied non-sterile for single-use, and was cleared via FDA 510(k) under K190306.
Frequently asked questions
What is the AMD Ritmed AssureWear VersaGown used for?
The AMD Ritmed AssureWear VersaGown is an isolation gown designed to provide fluid protection, breathability, and comfort during medical procedures. It is classified as a surgical isolation gown and is intended for use in settings requiring barrier protection against fluids, such as general and plastic surgery environments.
How is the AMD Ritmed AssureWear VersaGown supplied and is it sterile or reusable?
The AMD Ritmed AssureWear VersaGown is supplied non-sterile and is designed for single-use only. It is not intended to be reprocessed or reused, as reusing the gown could compromise its fluid protection barrier and increase contamination risk.
What design features does the AMD Ritmed AssureWear VersaGown include for ease of use and safety?
The gown includes thumb loops, extended thumb loops, and elastic cuff options to secure sleeves during use. It also incorporates patented Flexneck™ technology, which allows for fast and easy over-the-head donning and safe doffing to help prevent self-contamination during removal.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ritmed® AssureWear™ VersaGown™ Isolation Gown with ... - Medicom, Ritmed® AssureWear™ VersaGown™ Isolation Gown with ... - Medicom, AssureWear VersaGown Isolation Gowns with Flexneck Technology, AMD Ritmed AssureWear VersaGown (K190306) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190306 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AMD Medicom Inc
- FDA Applicant
- Amd Medicom, Inc.
Sources (1)
- FDA 510(k) K190306 24 fields · synced Sep 27, 2026